Due to recent advances in biotechnology, particularly in the field of molecular biology, there has been significant progress in the treatment of diseases previously intractable, including cancers, genetic diseases, autoimmune disorders and AIDS. Many of these advances are achieved through the administration of nucleic acid molecules to a subject, often human. Often the administered nucleic acids are oligonucleotides.
The present invention is particularly drawn to compositions and methods for modulating the production of selected proteins or other biological effectors in an animal, which involves the administration of nucleic acids, including oligonucleotides such as, for example, antisense oligonucleotides, to the dermis and epidermis of an animal.
Various modes of administration of oligonucleotides to subjects have been shown to be effective for delivery of oligonucleotides to particular tissues or organs for the treatment of several diseases and/or disorders. For example, U.S. Pat. No. 5,595,978, issued Jan. 21, 1997, to Draper et al., discloses intravitreal injection as a means for the direct delivery of antisense oligonucleotides to the vitreous humor of the mammalian eye for the purpose of treating viral infections thereof. To date, however, attempts to effectively deliver oligonucleotides to the dermis and epidermis have not been realized.
The topical administration of oligonucleotides offers the promise of simpler, easier, and more effective delivery of nucleic acids to the epidermis and dermis without the need for sterile procedures and their concomitant expenses (e.g., hospitalization, physician fees, etc.). Thus, there is a need to provide compositions and methods for the topical delivery of oligonucleotides to the epidermis and dermis, and to selected strata therein, of an animal. It is desirable that such novel compositions and methods provide for the simple, efficient and convenient delivery of therapeutic nucleic acids, especially oligonucleotides.